Romidepsin
Histone Deacetylase (Hdac) Inhibitors
Sold as ISTODAX
- Drug class
- Histone Deacetylase (Hdac) Inhibitors
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 2
- Products on record
- 2
- FDA reports (12 mo)
- 49
Overview
Romidepsin is an active pharmaceutical ingredient in the Histone Deacetylase (Hdac) Inhibitors group (L01XH). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | January 31, 2023 |
| CA Canada | Health Canada | 1 | January 13, 2026 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
How to take
CACanada· Health Canada
1 product
Uses
ISTODAX® (romidepsin for injection) is indicated for: • the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy.
Approval is based on response rates demonstrated in a single-arm trial (see 14 CLINICAL TRIALS). Improvement in overall survival has not been demonstrated with ISTODAX. The clinical benefit of ISTODAX in the relapsed/refractory PTCL setting remains unconfirmed.
ISTODAX should not be initiated in new patients outside of an investigational setting. Distribution Restriction ISTODAX is only available through the Restricted Access Program to patients currently receiving treatment with ISTODAX. Prescribers must register their patients under the Restricted Access Program to prescribe and dispense the product.
ISTODAX will be withdrawn from the Canadian Market after the last patient terminates treatment with ISTODAX. com. 1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of ISTODAX in pediatric patients has not been established.
Drug interactions
Known interactions involving Romidepsin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 336. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 03b39d40-90fe-11… · revised January 31, 2023 [PDF]
- [2]Health Canada (DPD) · 02414295 · revised January 13, 2026
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.